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Product name:
Sobantil
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Generic name:
Fenofibrate
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Dosage form:
Oral capsules
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Packaging:
Sobantil 100: Box of 4 blisters of 15 capsules/ Sobantil 200: Box of 5 blisters of 10 capsules
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Drug Category:
Cardiovascular
Indications:
Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Dosage and Administration:
Hypersensitivity to the active substance or to any of the excipients.
Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality)
Known gallbladder disease
Severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m2)
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Contraindication:
Adults: The recommended dose is 200 mg daily administered with a meal.
Geriatric: The recommended dose is 100 mg daily administered with a meal. If needed, adjust dosage up to 200 mg once daily. •Mild renal failure (CrCl >= 80 mL/min): No dose adjustment is necessary.
Moderate renal failure (CrCl 30-80 mL/min): The recommended dose is 100 mg daily administered with a meal.
Severe renal failure (CrCl <=30 mL/min): Contraindicated.
